Talphera (TLPH) Q1 2026 Earnings Transcript

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DATE

Wednesday, May 13, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Vincent J. Angotti
• Chief Financial Officer — Raffi Mark Asadorian
• Chief Medical Officer — Shakil Aslam

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TAKEAWAYS

• Cash Balance -- $21.1 million as of March 31, 2026, with management stating this is sufficient, along with future potential financing tranches, for operations through at least targeted Niyad PMA approval.
• Clinical Trial Enrollment -- Management announced “well exceeded” the 50% enrollment milestone in the nephro CRRT study, providing momentum toward completing final enrollment this year.
• Financing Tranches -- A $4.1 million financing tranche was closed during the quarter; two further conditional tranches totaling $16 million remain, contingent on achieving top-line data and study completion later this year.
• Operating Expenses -- Cash operating expenses (R&D plus SG&A) totaled $3.9 million, up from $2.9 million for 2025; excluding noncash stock-based compensation, these were $3.7 million versus $2.7 million.
• Clinical Site Activation -- Of 12 sites activated, 9 meet the new target site profile with nephrologists as principal investigators; these have enrolled more than 90% of study patients.
• Future Site Expansion -- The company expects two additional large CRRT sites to join, reaching the FDA-allowed limit of 14 trial sites, which management indicated will build clinical momentum for subsequent commercialization efforts.
• Top-Line Data Timing -- Raffi Mark Asadorian said, “top line data, which should come within a month after that last patient out,” and that the primary and secondary endpoints are completed within 24 and 72 hours, respectively, expediting data readout.
• Protocol Efficiency -- About 70% of patients reached the desired activated clotting time range on starting dose at 15 minutes, with the remainder requiring one or two titrations to target within one hour.
• Investigator Feedback -- Principal investigators and nursing staff have given positive feedback regarding the “simplicity” and “stability” of the protocol's administration and monitoring requirements, with minimal variability in laboratory parameters.
• Current Standard of Care at Sites -- Ten out of twelve sites do not use a consistent first-line anticoagulant, relying on heparin or citrate only as rescue therapies rather than for routine use.

SUMMARY

Management confirmed anticipated completion of clinical trial enrollment and data readout in the second half of 2026, reinforcing expectations for timely study progress and PMA filing. The ongoing addition of major CRRT sites and efficient protocol performance could enhance clinical trial influence and downstream adoption if Niyad achieves regulatory approval. The company's present liquidity, paired with future contingent financing, underpins operational continuity through planned regulatory milestones.

• Vincent J. Angotti stated the company “So we are not planning on any additional enrollment updates in particular realizing that the balance of the study is not tied to any tranches until the closure of the study.” between now and final enrollment, with the next major communication being the announcement of last patient out followed by top-line data.
• Niyad’s protocol does not require dose adjustments based on organ function, distinguishing it from existing anticoagulant drugs like heparin and citrate at study sites.
• Specialist principal investigators responded favorably to standardized titration and reduced monitoring workload, especially when compared to historic protocols with heparin and citrate.

INDUSTRY GLOSSARY

• CRRT: Continuous Renal Replacement Therapy; a form of dialysis used for critically ill patients with acute kidney injury.
• PMA: Premarket Approval; the FDA regulatory pathway for high-risk medical devices or drug-device combinations.
• Activated Clotting Time (ACT): A bedside laboratory test measuring the time it takes for blood to clot, used to monitor anticoagulation during medical procedures.

Full Conference Call Transcript

Vincent J. Angotti: Thanks, Raffi. Good afternoon. And thank you to everyone joining our call today. it is been less than 2 months since our last update, and we are excited about the progress we have made this year in the nephro study with our ongoing enrollment at current clinical study sites activation of additional sites achievement of the 50% enrollment milestone, and consequently, the closure of an additional financing tranche. With this continued progress, we believe we are well positioned to complete enrollment in the nephro CRRT study this year. and file a PMA for a targeted potential approval of NIAID in 2027. As mentioned, in early March, we announced the attainment of the 50% enrollment milestone in the nephro study.

With continued enrollment since that date, I am pleased to report that we have well exceeded this level. The protocol changes we adopted last year supported by bringing on new target profile clinical study sites that position us to achieve our goal of completing the study this year. Building on our virtual investor and analyst event in March, we continue to be genuinely excited about completing this study and submitting our PMA for potential approval of NIAID. The KOLs who participated in our March event highlighted the disadvantages with the currently available anticoagulants they are using. And their belief that Nefamostat will fill an unmet need in this market.

These insights as well as our ongoing discussions with other nephrologists, further reinforce our belief that NIAID could have an important role in anticoagulation for CRRT if approved by the FDA. 9 of our 12 activated sites align with the new target site profile that we set last year. And with nephrologists as the lead, these sites have enrolled over 90% of the patients in the study. The quality of our study sites and the principal investigators and their teams is excellent. Dr. Azim and I have been actively visiting many of the sites over the past several weeks and all of them are highly engaged and have expressed their desire to have a new CRRT anticoagulant approved for use.

In addition, we look forward to welcoming a couple of additional institutions who have been enthusiastic to participate in the study, allowing us to maximize the 14 sites granted by the FDA. While these new sites will find us further along in enrollment, they have been drawn to the Nephros study by a deep appreciation for Nefamostat's nearly 4 decades of use outside the U.S. and a strong interest in contributing to U.S. research with their peers on a potentially new approved CRRT anticoagulant. Adding these final sites helps lay the groundwork for broader clinical awareness of Nefamostat. Which will serve us well if the FDA approves it next year.

With that, I will now hand the call over to Raffi. To update you on the financial results for the first quarter.

Raffi Mark Asadorian: Thank you, Vincent. Our cash balance at 03/31/2026, was $21.1 million. We believe this cash, combined with future conditional financing tranches, will provide us sufficient capital through at least a potential NIAID PMA approval expected next year. During the quarter, we closed a $4.1 million financing tranche from the March 2025 private placement. There are 2 remaining conditional financing tranches totaling approximately $16 million of additional capital which, if the conditions are met, are expected to close around the date we release our top line data and announce completion of the study later this year. Our cash operating expenses or combined R&D and SG&A expenses for the 2026 totaled $3.9 million compared to $2.9 million for 2025.

Excluding noncash stock based compensation expense, these amounts were $3.7 million for the 2026 compared to $2.7 million for 2025. The increase in cash operating expenses in the 2026 was primarily due to higher NIAID development expenses reflecting increased enrollment and an increase in certain G&A expenses. I will now turn the call back over to Vincent.

Vincent J. Angotti: Thank you, Raffi. And I would like to open the line for any questions you might have. Operator?

Operator: Thank you. Ladies and gentlemen, we will now begin the Q&A Should you have a question, please press star followed by the 1 on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, press the star followed by the 2. If you are using a speakerphone, please lift the handset before pressing any key. Your first question comes from the line of James Francis Molloy from Alliance Global Partners. Please go ahead.

Analyst (Matt): Hey, guys. Matt on for Jim today. I am just wondering if you guys are going to announce enrollment and any other milestone, maybe 75%, or is the next update going to be full enrollment and then where to expect data quickly after? Thanks.

Vincent J. Angotti: Yeah, Raffi, I will start it and then you can give them an idea of the kind of data communication we are planning. So we are not planning on any additional enrollment updates in particular realizing that the balance of the study is not tied to any tranches until the closure of the study. Until the study is being completed. With that said, I think Raffi can communicate to you what our expectation is upon study completion or enrollment completion being last patient out. And how we plan to communicate data thereafter.

Raffi Mark Asadorian: Yeah, sure. Yeah, I think we will announce last patient out But the most important is the top line data, which should come within a month after that last patient out. Remember, it is a very quick study, 72 hours at the secondary endpoint, 24-hour primary endpoint. So it is a quick study, and we are cleansing the data along the way. So it will be a quick announcement for that top line top line data.

Analyst (Matt): Got it. Thank you. And is there any guidance you can give as to where you might be now or timing going forward, second half 26 still looking like the most likely for a top line read.

Vincent J. Angotti: Yeah, the second half of 2026. You know, the study goes in ebbs and flows and so we are going to remain on our guidance for the 2026. Depending on the flow of those qualifying patients moving forward. But we are confident in it being completed this year. And announcing those results this year.

Analyst (Matt): Great. Thanks for taking my questions, guys.

Vincent J. Angotti: Thanks, Matt.

Operator: Your next question comes from the line of Ed Arce from WestPark Capital. Please go ahead.

Antonio Eduardo Arce: Hi, Vincent and Raffi. Good to be with you. Congrats on the continued progress. Just a couple of quick questions for me. As we anxiously await full enrollment and top line data later this year.

The first 1 is these 2 new sites that you expect to come online pretty soon here, and basically cap out the full complement of sites would you be able to disclose which sites those are or perhaps give a qualitative description of the type of site and the type of patients that they see And then the other question is, have you received any commentary from site administrators that are treating the patients, anyone that is conducting the study, any commentary that you could share with us about how things are progressing? Thanks so much.

Vincent J. Angotti: Yeah. I will start with the new sites, Ed. And then I will turn it over to Shakil to give a little more insight on those sites and the site administrators' feedback. The 2 new sites we do not expect to be significant contributors to the study. But they have significant CRRT populations. I say it not to be significant contributors to study because they are coming in so late to the study, but they wanted to be involved moving forward. These are study sites that match our new profile with nephrologists being the lead. 1 of the sites in particular is 1 of the top 5 as far as our data suggests, CRRT-administering hospitals in the country.

And we will end up communicating those sites when we update clinicaltrials.gov on the study sites. So you will be able to see who those sites are specifically in conjunction with all the balance of the sites we have to round out the 14. As it relates to the site administrators, and how it is going, I think Shaquille's best positioned to communicate that while he and I have been making our rounds over the last several weeks Remember, it is a blinded study, but I think what is important about this is the placebo and the product are treated similar in the protocol.

Shakil Aslam: And the simplicity that comes with it. So, Shakil, Sure. Thanks, Ed. Absolutely. So when we talk to the PIs and the investigators, and then as well as the nurses who are running this study and who are doing testing and looking at some of the test results They are all very, very impressed with the ease of administering this intervention. As Vin said, both placebo as well as NIAID, they are administered exactly the same way. And, sure for the first 24 hours, we have a little bit more intense, monitoring, of blood tests, to see how patients are responding to it. But after 24 hours, you know, that intense goes down.

And then they basically all are very, very impressed that how little variability they are seeing in the test results. So that is quite a pleasant surprise to them that they do not have to chase their tails trying to keep some, you know, the parameters within target range. Once they have somebody stable, at a parameter, lab parameter, they basically stay the same value. So overall, I think Thank you. Everybody is yeah.

Vincent J. Angotti: Shakil, could you comment on the reach or the conclusion of that stability to get to the proper dose in that first hour? And why that protocol works for them. And how we are basically controlling that primary endpoint on that first hour.

Shakil Aslam: Right. So as you know, in this study, we start at a starting dose, which is predefined. And 15 minutes later, we check the activated clotting time by a handheld device by the bedside, which we provide, and we provide the cartridges as well. So it is pretty standardized test across all sites. And within 15 minutes, they check the value and we have a certain range in which we want that value to be. So about 70% of, the cases, you see the ACT going in that range right, at the first starting dose. Occasionally, a patient, less than 25%, may need 1 and a couple of them may have needed even more than 1 titration, 2 titrations.

Which is by the end of the first hour, everybody is in the range. In which they are expected to be. Obviously, you know, I am not going to disclose for different groups because there is 1 placebo in which we expect the value to change much but has expected their value to change. In active treatment, the value changes, but they remain within that range. So this it is a very, very stable response. Which is not a total surprise to us because Nefamostat's metabolism is really not dependent on any specific organ. So there are other drugs which are dependent on liver or kidneys or any other organ for metabolism.

And every time the function of those organs deteriorates, or changes, you can see different response. And the whatever parameter you are following. Whereas, Nefamostat, it really is not dependent on any organ. Most of these patients, they can have fluctuating organ function. Can affect other medications such as heparin being 1 example. Citrate is another example. If you have liver failure, citrate will not be metabolized as quickly. Nefamostat does not have those issues. So that is the reason why once you hit the target level, it essentially remains stable. Does that answer your question?

Antonio Eduardo Arce: Yeah, yeah, sure. Yeah, that is--I could add a little Thank you.

Vincent J. Angotti: Shakil, a little bit more color. So on the administrative side, can you comment to the people on the line how many of the sites are typically using citrate as a primary intervention for anticoagulation and CRRT, and/or heparin as a primary intervention both anticoagulation and CRT.

Shakil Aslam: Sure. So of the 12 sites that we have we do not have any site that uses citrate. As a standard of care. So there are 2 or 3 sites that will use citrate. Only if a patient continues to clot. And these sites do not use heparin at all, so the sites that are using citrate, they do not use heparin. So they do, 3 sites that have access to citrate. They are not citrate first users, only use citrate as a--as citrate is the only rescue they have. We have 2 sites, only 1 site that uses heparin as standard of care of all the sites that we have.

Then we have 2 or 3 sites that use heparin as a rescue therapy. So they do not use either citrate or heparin, when the CRRT started. But if they see clotting, they do not have access to citrate, so then they go back to rescue heparin. Majority of our sites right now, I would say, you know, 10 out of 12 or 13 that we have, they really do not have any first-line anticoagulant that they use for every single patient. They are really using, either heparin or citrate as a rescue. And we do not have any site that uses citrate for everybody.

Vincent J. Angotti: And I think, importantly, Ed, when they execute the protocol in the nephro study, and the titration schedule, they see the ease of use, whether it is placebo or active does not matter. Placebo or active does not matter. it is just the ease of that titration schedule compared to what their historic challenges have been with heparin and citrate, and that seems to be the additional feedback.

Shakil Aslam: Simplicity, right, is the main comment. Right. And nurses, even we spoke visiting a site today and the nurses were like shocked, "Okay, we do not have to do anything else. No. that is it. that is all the monitoring that is required.

Antonio Eduardo Arce: So that is very helpful. Thank you both.

Shakil Aslam: Sure.

Operator: Thank you. There are no further questions at this time. I will now turn the call over to Vincent. Please continue.

Vincent J. Angotti: Thank you, operator. And I will just clarify my comment I said earlier about the site names, the additional 2 that will be coming on that will be on clinicaltrials.gov. Excuse me. And our next update of those sites. So again, thank you all for joining us on our first quarter earnings call. We are really very high on what is happening at the 2026 and the enrollment that is continuing to move forward. The NEPHRO study progress has been excellent. Our commitment, enthusiasm, to bring the potentially new regional anticoagulant for CRRT to the market next year is unwavering. So we appreciate your attendance today.

And we are very excited about the future for the nephro study as well as Talphera moving forward. We will provide you additional updates on our progress, and thank you for joining us on the call Operator, that concludes our call.

Operator: Thank you very much. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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